Perifosine in Treating Patients With Metastatic, Androgen-Independent Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00060437|
Recruitment Status : Completed
First Posted : May 7, 2003
Last Update Posted : June 19, 2013
RATIONALE: Drugs used in chemotherapy such as perifosine use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of perifosine in treating patients who have prostate cancer that no longer responds to androgen ablation therapy.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: perifosine||Phase 2|
- Determine the 4-month progression-free survival rate, as measured by prostate-specific antigen and clinical criteria, in patients with metastatic androgen-independent prostate cancer treated with perifosine.
- Determine the side-effect profile of this drug in these patients.
- Determine the pharmacokinetics and pharmacodynamics of this drug in these patients.
- Course 1: Patients receive oral perifosine twice on day 1 and once daily on days 2-21.
- All subsequent courses: Patients receive oral perifosine once daily on days 1-21.
In all courses, treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 22-46 patients will be accrued for this study within approximately 1.5 years.
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial Of Oral Perifosine In Patients With Metastatic Androgen Independent Prostate Cancer|
|Study Start Date :||October 2003|
|Actual Study Completion Date :||April 2004|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00060437
|United States, Maryland|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support|
|Bethesda, Maryland, United States, 20892-1182|
|Study Chair:||Edwin M. Posadas, MD||National Cancer Institute (NCI)|